Which asthma patient has allergic airway inflammation? C o n t r o l l i n g A l l e r g i c A s t h m a
Several underlying diseases can present symptoms similar to asthma. Therefore, a correct diagnos is relies on establishing whether or not the patient is characterized by allergic airway inflammation. Until recently, diagnostic devices have not been able to convey a complete clinical over view and clearly identify the underlying cause of the symptoms. Consequently, patients that are not suffering from asthma have received unnecessary or inadequate treatment. 1 Patients with asthma symptoms due to allergic inflammation will respond favorably to inhaled corticosteroids, while those who are suffering from other airway disorders may not. 2, 3 Measuring exhaled NO (FENO) helps to eliminate the uncertainties and discrepancies that contribute to asthma morbidity and mortality, including incorrect diagnosis and poor adherence to treatment. Nitric Oxide (NO) a marker of inflammation Monitoring asthma symptoms is important, but correct interpretation of the underlying inflammation determines the therapy. Measuring exhaled NO provides an immediate answer to three critical questions: 1 Which patients with non-specific or multiple respiratory symptoms have allergic airway inflammation? 2 Is the patient adhering and responding to the prescribed therapy? 3 Has there been a change in allergen exposure?
1 NIOX MINO instantly reveals allergic inflammation of the airways 4 Asthma Chronic cough Cardiac disease COPD Patient with chronic cough or symptoms suggestive of asthma Infections Bronchitis GERD Vocal Cord Dysfunction History, symptoms, FENO measurement Normal FENO Elevated FENO Consider: Diagnosis other than (allergic) asthma Strong predictor of allergic asthma (or eosinophilic bronchitis) ICS responsiveness likely Management and control
2 NIOX MINO instantly reveals if the patient is compliant with anti-inflammatory therapy 5 In the clinical workup of the asthma patient there are several questions that must be answered; Is the airway inflammation under control? Is the patient responding to the therapy? Does the patient take the medication? Is the patient using correct inhalation technique? In clinical practice NIOX MINO will immediately identify the non-compliant patient or the patient with an inadequate drug delivery technique. It will also confirm uncontrolled airway inflammation. NIOX MINO is the device of choice used globally for measurement of airway inflammation in clinical practice and in clinical studies. The performance of NIOX MINO is documented in more than 30 clinical papers in peer-reviewed journals.
Continuous follow-up and evaluation Symptoms + NO measurement = An objective measurement of: Therapy response Patient compliance to therapy Drug delivery = Inflammation control Control of inflammation is needed in asthma to reduce exacerbation frequency. M. Thomas et al. High-dose inhaled corticosteroids versus add-on long-acting betaagonists in asthma: an observational study. J Allergy Clin Immunol. 2009;123(1):116-121.
3 NIOX MINO reveals changes in allergen exposure 6 Anti-inflammatory treatment can become ineffective for patients who are highly exposed to household and work-place allergens, especially if they are subjected to continuous exposure. Despite optimal anti-inflammatory therapy, the rapid onset of allergic rhinitis and conjunctivitis, or continued respiratory symptoms, can indicate significant exposure to unidentified allergens. High NO values indicate the presence of inflammation and alert the physician and patient to these conditions, suggesting the need for a change in therapy.
NIOX MINO maintenance and calibration free NO-measurement The only calibration and maintenance-free NO device All NO values quality assured Individualized data management for the practice and the patient Maintenance and calibration free Procedure Exhale to empty the lungs Inhale deeply through the disposable filter Exhale through the filter View results on screen The procedure can be followed by either the audio or visual feed-back. When the procedure is finished, measurement results are available within a couple of minutes.
Connectivity with individualized Data Management Electronic storage and display of patient data Prepared for direct communication to patient Electronic Medical record (EMR). Convert patient data into a PDF report. Visual Incentive Program Practice and patient specific information material USB
Visual Incentive Cable (USB) or wireless (Bluetooth) connection to a PC makes it possible to follow the procedure on the PC screen. Nasal research application With the NIOX MINO Nasal Application nasal NO concentration can be measured in gas aspirated from a nostril using passive sampling. Additional parts are needed to run this application.
Guide to interpretation of quality assured values from NIOX MINO in patients with airway disease LOW NORMAL INTERMEDIATE HIGH Allergic airway inflammation Unlikely Unlikely Present, but mild Significant ADULTS FENO value (Fractional Exhaled Nitric Oxide) <5 5 25 25 50 >50 (or a rise of > 60% since previous measurement) CHILDREN < 12 years FENO value (Fractional Exhaled Nitric Oxide) <5 5 20 20 35 >35 (or a rise of > 60% since previous measurement) * Adapted from Taylor DR, Pijnenburg MW, Smith AD, De Jongste JC. Exhaled nitric oxide measurements: clinical application and interpretation. Thorax 2006; 61: 817-27. References 1. Aaron SD, Vandemheen KL, Boulet LP, McIvor RA, Fitzgerald JM, Hernandez P, Lemiere C, sharma S, Field SK, Alvarez GG, Dales RE, Doucette S, Fergusson D; Canadian Respiratory Clinical Research Consortium, Overdiagnosis of asthma in obese and nonobese adults. CMAJ. 2008. 18;179(11):p. 1121-31. 2. Berry, M.A., D.E. Shaw, R.H. Green, C.E. Brightling, A.J. Wardlaw, and I.D. Pavord, The use of exhaled nitric oxide concentration to identify eosinophilic airway inflammation: an observational study in adults with asthma. Clin Exp Allergy, 2005. 35(9): p. 1175-9. 3. Smith, A.D., J.O. Cowan, K.P. Brassett, S. Filsell, C. McLachlan, G. Monti-Sheehan, g. Peter Herbison, and D. Robin Taylor, Exhaled nitric oxide: a predictor of steroid response. Am J Respir Crit Care Med, 2005. 172(4): p. 453-9 4. Sandrini A, Taylor DR, Thomas PS, Yates DH, Fractional exhaled nitric oxide in asthma: an update. Respirology. 2010;15(1): p: 57-70. 5. Szefler, S.J., H. Mitchell, C.A. Sorkness, P.J. Gergen, G.T. O Connor, W.J. Morgan, M. Kattan, A. Pongracic, S.J. Teach, G.R. Bloomberg, P.A. Eggleston, R.S. Gruchalla, C.M. Kercsmar, A.H. Liu, J.J. Wildfire, M.D. Curry, and W.W. Busse, Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet, 2008.372(9643): p. 1065-72. 6. Vahlkvist, S., M. Sinding, K. Skamstrup, and H. Bisgaard, Daily home measurements of exhaled nitric oxide in asthmatic children during natural birch pollen exposure. J Allergy Clin Immunol, 2006. 117(6): p. 1272-6.
Aerocrine is continuously developing and documenting NO measurement as a valuable tool in the management of airway disease. More than 4 million tests in clinical practice prove its efficacy. Continuous ground-breaking development Aerocrine developed the first instrument for measurement of exhaled NO Aerocrine instruments will remain the Gold Standard for FENO measurement Aerocrine has close collaboration with the world s leading NO scientists Aerocrine will continue to lead the development of NO as a marker of airway inflammation The International Space Station is using the NIOX MINO to evaluate the effects of inhaling oxygen-rich air and spacewalking on astronauts, who are preparing to work in the stratosphere the ultimate point-of-care testing! A new dimension in asthma care www.nioxmino.com www.aerocrine.com Aerocrine AB, P.O. Box 1024, SE-171 21 Solna, Sweden Phone: +46 8 629 07 80, Fax: +46 8 629 07 81, E-mail: info@aerocrine.com NIOX MINO is CE marked according to European In Vitro Diagnostic Device Directive 98/79/EEC and 510(k) cleared (K101034) by FDA. Copyright 2010 Aerocrine AB, Solna, Sweden. Aerocrine, NIOX MINO and NIOX are registered trademarks of Aerocrine AB. US Patent 5,447,165, US Patent 5,922,610, US Patent 6,038,913, US Patent 6,063,027, US Patent 6,099,480, US Patent 6,183,416, US Patent 6,511,425, US Patent 6,626,844, US Patent 6,723,056, US Patent 6,733,463, US Patent 6,761,185, US Patent 7,014,692, US Patent 7,270,638, US Patent D448,693, US Patent D457,231, US Patent D492,035, US Patent D496,667 and patents pending. EMD-000382-01 November 2010